Study of Single Agent Belantamab Mafodotin Versus Pomalidomide Plus Low-dose Dexamethasone (Pom/Dex) in Participants With Relapsed/Refractory Multiple Myeloma (RRMM)

Фаза 3 Идёт, набор закрыт NCT04162210

Кратко

This open-label, randomized study for evaluating the efficacy and safety of single agent belantamab mafodotin when compared to pom/dex in participants with RRMM. Participants will be randomized in a 2:1 ratio to receive either single agent belantamab mafodotin or pom/dex. Belantamab mafodotin will be administered on Day 1 (D1) at every 3 weeks (Q3W) schedule. Pomalidomide will be administered daily on Days 1 to 21 of each 28-day cycle, with dexamethasone administered once weekly (Days 1, 8, 15, and 22). Participants in both arms will be treated until disease progression, death, unacceptable toxicity, withdrawal of consent, and lost to follow-up or end of study, whichever comes first.

Progression-Free Survival (PFS) Based on Investigator-Assessed Response as Per International Myeloma Working Group (IMWG)

Up to 27 months · Months

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• Lenalidomide in Treating Patients With Multiple Myeloma Undergoing Autologous Stem Cell Tr — National Cancer Institute (NCI)
• Lenalidomide and Dexamethasone With or Without Bortezomib in Treating Patients With Previo — National Cancer Institute (NCI)
• Phase 2 Study With Minimal Residual Disease (MRD) Driven Adaptive Strategy in Treatment fo — University of Michigan Rogel Cancer Center
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Все исследования